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NCT07571811 · ClinicalTrials.gov registry record

Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery

A clinical trial, sponsored by Boston Children's Hospital.

Not yet
Registry status
10
Enrollment target

NCT07571811: Clinical Trial study, sponsored by Boston Children's Hospital.

NCT07571811 is a clinical trial that has not yet begun recruiting, run by Boston Children's Hospital. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07571811 has not yet begun recruiting, sponsored by Boston Children's Hospital.

NOT YET RECRUITING
Registry status
10 participants
Enrollment target

Study Summary

This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology), and how they transfer between mother and fetus through the placenta. The secondary goal is to measure drug levels in discarded fetal blood samples collected during clinically indicated procedures and relate those levels to fetal heart rate, heart rate variability, movement, gestational age, and fetal size. An optional maternal blood draw component will allow comparison of maternal and fetal drug concentrations to better understand placental transfer. The study does not change clinical care or require extra fetal procedures, and findings may help create safer, evidence-based fetal anesthesia dosing strategies tailored to gestational age.

Primary Outcome

Characterize the plasma concentrations / pharmacokinetics profile, specifically the peak plasma concentration (Cmax) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2026-05-01
Est. Completion 2027-05-01
Boston Children's Hospital

462 total trials

What is known before NCT07571811 opens enrollment

NCT07571811 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT07571811 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07571811 about?

NCT07571811 is a clinical study titled "Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery". This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology),...

What is the current status of trial NCT07571811?

This trial is currently not yet recruiting. The enrollment target is 10 participants. The study started on 2026-05-01. Estimated completion is 2027-05-01.

Who is sponsoring clinical trial NCT07571811?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT07571811, the US trial registry maintained by the National Library of Medicine. NCT07571811 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.